In a ruling that will help patients continue to buy several life-saving
medicines as generic drugs, the Supreme Court on Monday April 1,2013 held that the
modification of a well known cancer-fighting drug is not a patentable
new invention.
A Bench of Supreme Court Justices Aftab Alam and Ranjana Desai said: “We
firmly reject the appellant’s case that Imatinib Mesylate is a new
product and the outcome of an invention beyond the Zimmermann [original]
patent.”
The Bench said that the patent application contains a “clear and
unambiguous averment” that all the therapeutic qualities of the modified
form, for which the patent was applied, “are possessed” by the original
version.
The court held that patents can be granted only for medicines that are
truly new and innovative. For new forms and new uses of existing
medicines, patent applicants should prove improved efficacy.
The judgment allows suppliers to continue making generic copies of Swiss
firm Novartis’ Glivec or Gleevec, which has been shown to fight chronic
blood cancer effectively. While the Novartis drug costs more than Rs 1
lakh per month, with doctors often advising patients to take it
lifelong, the generic equivalents cost less than one-tenth.
The ruling
would be a relief to some 300,000 patients in India currently taking the
drug.
Note
Glivec is the brand name of Imatinib. Novartis had applied for a patent
for a modification of this drug, a “beta crystalline” salt form of
Imatinib Mesylate or IM, which it said could be better absorbed by the
body – by up to 30% more.
After its patent application was rejected by
the Patent office, Novartis moved the Intellectual Property Board,
Chennai. The Board rejected the claim, but gave certain findings
favourable to the company. Instead of filing an appeal before the Madras
High Court, Novartis moved the Supreme Court.
Timeline
1997: Novartis files a patent application in India for its drug Gilvec
2005: India introduces the Indian Patent Act preventing frivolous patents.
Jan 2006: The Patent Controller in Chennai denies Novartis a patent
May 2006: Novartis challenges the Indian government and four other companies in the Madras High Court
Aug 2007: The Madras High Court rules against Novartis’ case
June 2009: The Intellectual Property Appellate Board rejects a fresh appeal
August 2009: Novartis approaches the Supreme Court of India
April 1, 2013: Supreme Court rejects Novartis’ plea for patent
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